Jobs in the United States

25+ jobs

Save this search

Added 1 hour ago
Manufacturing Engineer
Kubota
Gainesville, GA
CAD Design Specialist: Develop design records for tooling and fixtures using CAD applications, ensuring proper storage and organization of records.
Added 1 hour ago
Manufacturing Engineer
Kubota
Gainesville, GA
Tooling and Fixture Design: Utilize CAD applications to develop and maintain design records for tooling and fixtures, ensuring accuracy and accessibility.
Added 1 hour ago
Engineering Summer College Internship
Kubota
Gainesville, GA
Experience with CAD software such as AutoCAD, Inventor, SolidWorks, or similar programs.
Added 1 hour ago
Manufacturing Support Summer College Internship
Kubota
Gainesville, GA
Exposure to CAD software, XVL, or other manufacturing documentation tools.
Added 1 hour ago
Design Quality Engineer
Kubota
Gainesville, GA
Exposure to quality engineering tools and methodologies (e.g., FMEA, control plans, CAPA)
Added 1 hour ago
Engineering Refrigeration Technician 1
Hoshizaki America
San Antonio, TX
Operate refrigeration equipment and tools like copper brazing torches, vacuuming systems, refrigerant charging systems, thermal sensors and data acquisition devices, etc.
Added 1 hour ago
Engineer Tech - Temp
Hoshizaki America
San Antonio, TX
The ability to read engineering drawings and use measuring tools
Added 2 hours ago
GIS Associate
SAIC
California, MD
Demonstrated experience converting multiple data types (e.g., non-geospatial tabular data, CAD files) into standardized, geospatial formats.
Added 2 hours ago
NPI Engineer - Alpena Area
The Pivot Group Network
Alpena · Alpena, MI
Working knowledge of process validation and root cause tools.
Added 2 hours ago
Assistant, Hardware & Trim RTW
alexanderwang
NY · New York, NY
Advanced Excel proficiency; CAD or design software knowledge a plus.
Added 3 hours ago
Manufacturing Engineering Ops Co-Op (Summer/Fall 2027)
Collins Aerospace
Melbourne, FL
Apply Six Sigma tools in a practical setting.
Added 3 hours ago
Manufacturing Engineering Ops Co-Op (Spring/Summer 2027)
Collins Aerospace
Melbourne, FL
Apply Six Sigma tools in a practical setting.
Added 3 hours ago
Textile Design Manager
FXI
Aston, PA
Proficiency with design and specification tools (e.g., Adobe Creative Suite, CAD/PLM, and tech-pack systems).
Added 3 hours ago
G
Electrical Design Engineer
GPAC
Russellville, AR
- $80,000 to $110,000 USD / year
Software Skills: Proficiency with industry-standard CAD software (e.g., AutoCAD Electrical, Altium Designer, OrCAD, or SolidWorks Electrical).
Added 4 hours ago
Mechanical Engineering Consultant 2 - Mission Critical
Sargent & Lundy
United States
Experience with CAD software (e.g., Solidworks, Inventor, Microstation, AutoCAD)
Added 5 hours ago
G
Electrical Design Engineer
GPAC
Rochester, NY
- $90,000 to $125,000 USD / year
Software Skills: Proficiency with industry-standard CAD software (e.g., AutoCAD Electrical, Altium Designer, OrCAD, or SolidWorks Electrical).
Added 6 hours ago
G
Electrical Design Engineer
GPAC
Burlington, MA
- $90,000 to $125,000 USD / year
Software Skills: Proficiency with industry-standard CAD software (e.g., AutoCAD Electrical, Altium Designer, OrCAD, or SolidWorks Electrical).
Added 6 hours ago
G
Electrical Design Engineer
GPAC
Brockton, MA
- $90,000 to $125,000 USD / year
Software Skills: Proficiency with industry-standard CAD software (e.g., AutoCAD Electrical, Altium Designer, OrCAD, or SolidWorks Electrical).
Added 6 hours ago
G
Electrical Design Engineer
GPAC
Chicago Heights, IL
- $90,000 to $125,000 USD / year
Software Skills: Proficiency with industry-standard CAD software (e.g., AutoCAD Electrical, Altium Designer, OrCAD, or SolidWorks Electrical).
Added 6 hours ago
G
Electrical Design Engineer
GPAC
Arkadelphia, AR
- $80,000 to $110,000 USD / year
Software Skills: Proficiency with industry-standard CAD software (e.g., AutoCAD Electrical, Altium Designer, OrCAD, or SolidWorks Electrical).
Added 6 hours ago
Manufacturing Process Engineer
Filtration Group Corp
Minneapolis, MN
…Fabrication operations by applying Lean manufacturing principles and tools to identify waste, improve process flow, increase efficiency, reduce variation, and establish sustainable standard…
Added 7 hours ago
Lead Advanced Manufacturing Engineer
HCC
Blacksburg, VA
Contribute to overall design and analysis using available technology tools and analytical methods (brainstorming, thought experimentation, etc.).
Added 7 hours ago
Licensed Architect
Heritage Business Group
Salem, OR
…schedules, permit documents, and contract documents using approved CAD and building information modeling software; maintain organized project records and…
Added 7 hours ago
Engineering Technician
ICHOR Candidate Experience
Tualatin, OR · Portland, OR
Commission and troubleshoot tools and test fixtures.
Added 7 hours ago
Controls Engineer 2
Hamilton Medical, Inc.
Reno, NV
Ability to read electrical schematics and use diagnostic tools to distinguish programming, electrical, mechanical, and process-related faults.

Sirtex

Staff Product Development Engineer

Woburn, MA, United States

$123,612 to $154,515 USD / year

Apply About employer

Applications open in a new tab.

Job details

Pay: $123,612 to $154,515 USD / year
Experience: BS in Biomedical, Mechanical or a related engineering discipline with 10+ years of medical device product development experience, or MS with 8+ years.
Posting language: English
Posted: Nov 6, 2026

Original job description

Company Description Sirtex Medical is a global leader in healthcare, with offices in the U.S., Australia, Germany, and Singapore, dedicated to improving patient outcomes. Our mission is to be at the forefront of minimally invasive cancer and embolization therapies. By partnering with physicians, we aim to provide innovative products that enhance patient outcomes and simplify treatments. Achieving this ambitious goal requires passionate and talented individuals who are committed to making a difference. Our flagship product, SIR-Spheres® Y-90 resin microspheres, is a targeted radiation therapy for liver cancer. To date, we have delivered over >150K doses across 50+ countries, significantly impacting patients' lives worldwide. Our success is fueled by our dedication to serving the medical community, maintaining professionalism, fostering a collaborative work culture, nurturing an entrepreneurial spirit, and continuously pursuing innovation and improvement. At Sirtex, we are committed to creating a great workplace. We offer a range of benefits, programs, and services to support our employees, ensuring they have opportunities to contribute to our success and advance their careers. Join our inclusive community, where you can collaborate with talented colleagues, bring your ideas to life, and advance your career, all while delivering innovative healthcare solutions to patients.

Job Description

About the role Sirtex Medical is hiring a Staff Product Development Engineer to serve as the senior individual-contributor technical authority. You will provide project leadership, own the technical integrity of design controls, verification, validation and regulatory submissions from concept through commercialization and sustaining. This is a hands-on leadership role. You will set technical direction for cross-functional teams, write and defend the evidence that gets products approved and keeps them on the market, and mentor engineers who will grow into the next generation of technical leads. Candidates must be local to the Boston, MA area and be willing to adhere to our hybrid work arrangements, currently 3 days/week in office and 2 days/week remote. Location: Woburn, MA - hybrid/on-site

Key responsibilities

Serve as project lead on one or more concurrent development programs, from user needs and design inputs through design transfer and commercial launch
Collaborate closely with Quality, Manufacturing, Regulatory and Marketing
Own Design History File content and lead formal design reviews, ensuring traceability from user needs to verification and validation evidence
Drive concept generation and feasibility work and protect resulting innovations through invention disclosures and patent filings
Engage marketing team and clinicians to define user needs and translate them into testable requirements
Lead and own Design Verification
Work in partnership with manufacturing and design quality to support transfer to manufacturing / Process Validation (IQ/OQ/PQ)
Manage external labs for testing including testing plan development, reports and assess the impact of design, material and supplier changes
Act as a subject matter expert for biological safety and provide strategy
Lead R&D modules of FDA submissions (PMA, PMA supplements, IDE, 510(k)) and EU MDR Technical Documentation, and respond to Regulatory and Notified Body questions
Partner with Quality on design risk management per ISO 14971, owning the engineering inputs to DFMEA/PFMEA and benefit-risk analysis
Participate in complaint investigations, root cause analysis and CAPA, and support FDA inspections and audits when needed
Partner with Quality and Manufacturing on product and process improvements
Mentor and develop engineers, including technical reviews of their protocols, reports and design decisions
Champion continuous improvement in engineering efficiency

Qualifications

BS in Biomedical, Mechanical or a related engineering discipline with 10+ years of medical device product development experience, or MS with 8+ years.
Demonstrated technical leadership of Class II and/or Class III PMA devices through design controls, design transfer and commercial launch required
Hands-on authorship of Design Verification, Test Method Validation and Process Validation (IQ/OQ/PQ) protocols and reports
Working command of 21 CFR 820 / QMSR, ISO 13485, ISO 14971 and ISO 10993
Clear, concise technical writing, and the ability to explain risk and trade-offs to executive leadership and non-engineering audiences
Experience in leading the R&D module in FDA PMA, IDE or 510(k) submissions
Experience leading root cause investigations, complaint handling and CAPA
Basic proficiency with 3D CAD tools (e.g., SolidWorks) and statistical analysis tools (e.g., Minitab, JMP) required
Hands-on experience with IEC 62366-1 and FDA HFE guidance including use-related risk analysis, formative studies, critical task identification, and summative (HF validation) testing and reporting will be a plus
Formal training in statistical problem-solving (such as Six Sigma) preferred
Track record managing or mentoring engineers, co-ops or interns
Experience in a growth-stage or startup environment, where wearing multiple hats was the norm

The anticipated annual base salary range and target bonus opportunity is $123,612 to $154,515 annually, plus a 10% target annual bonus. The final position level and compensation will be determined based on non-discriminatory, job-related factors, including geographic location, skills, experience, education, and alignment with the position requirements. In addition to base salary and bonus eligibility, Sirtex offers a comprehensive benefits package, including paid sick and vacation time, medical, dental, vision and life insurance, and a generous 401(k) matching program and other benefits, subject to applicable plan terms and eligibility requirements.

Additional Information All your information will be kept confidential according to EEO guidelines

Do you want to be part of something bigger? A team whose impact stretches across the globe making a real difference to the quality of people’s lives. Sirtex recognizes that well-being, financial health, and work-life balance are crucial for our employees to achieve personal success.

Sirtex offers qualified candidates:

Diverse and flexible work arrangements to achieve the optimum balance between work and personal responsibilities.
A culture of respect, diversity, collaboration, and innovation fostering inclusiveness and superior performance.
Attractive compensation and benefit packages which are practical, robust and equitable.
A commitment to support ongoing professional growth through career development, on the job experiences and training opportunities.
Challenging work which supports the development of new and better ways to improve clinical outcomes for oncology treatment around the world.
An unwavering commitment to company values, employee safety and excellence in everything we do.

Diversity drives innovation; inclusion fosters belonging, growth and success. Sirtex believes that it takes multiple perspectives and voices to create a culture and workplace which fosters engagement, teamwork, and employee satisfaction to perform our best and deliver on commitments. We are dedicated to fostering an environment where all employees feel valued, included, and can share their ideas so that we can exceed even our own expectations. Sirtex is An Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age or any other characteristic protected under applicable law. Sirtex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Apply About employer

Report this job